CLASS II Device recall · Reported 5 Mar 2014 · FDA Enforcement Report

VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System recalled

Terumo Cardiovascular Systems is recalling VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, distributed nationwide in the US. The recall was initiated on 12 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers: 21K, 31K, 32K, 33K, 34K, 35K

Quantity recalled26 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1069-2014
FDA event ID: 67193
Recalling firm: Terumo Cardiovascular Systems, Elkton, MD
Classification: Class II
Status: Terminated
Recall initiated: 12 Dec 2013
FDA classified: 21 Feb 2014
Reported: 5 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

12 Dec 2013	Recall initiated by company
21 Feb 2014	Classified by FDA	+71 days
5 Mar 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sterility of medical devices intended for use in surgical procedures may be compromised.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass.

Where it was distributed

USA Nationwide Distribution in the state of LA, NJ, and NY.

Nationwide Louisiana New Jersey New York

Questions about this recall

Is VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System recalled?

Yes. Terumo Cardiovascular Systems recalled VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System on 12 Dec 2013. The recall is Class II and its status is Terminated. Recall number Z-1069-2014.

Why was it recalled?

Sterility of medical devices intended for use in surgical procedures may be compromised.

Which lots are affected?

Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K

Where was it sold?

USA Nationwide Distribution in the state of LA, NJ, and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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